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The efficacy of platelet-rich plasma (PRP) in the treatment of low back pain remains largely unknown. Up until now, very few studies have looked at whether PRP can effectively treat low back pain caused by degenerative conditions. When considering back pain that is caused by a degenerating disc, common treatment options standardly include physical therapy, medications such as non-steroidal anti-inflammatory (NSAIDs), corticosteroid injections, radiofrequency ablation and in some cases, surgery. Unfortunately, while these treatment modalities may lessen the severity of clinical symptoms, none target the underlying pathology or as we all are looking for, reverse the aging and degenerative process.

A prospective, double blind randomized control trial published by Taukli-Wosornu et al (2016) analyzed 47 patients (27 in treatment group, 18 in control group) with degenerative disc disease as confirmed by provocative discography. Those in the treatment arm of the study received a single injection of platelet rich plasma (PRP) versus the control group who received an injection of a contrast agent into the painful disc. PRP (1-2 mL) was injected in discs determined to have concordant pain. Outcomes were based on the Functional Rating Index (FRI), Numeric Rating Scale (NRS) for pain, SF-36 (pain and physical function domains), and the modified North American Spine Society Outcome Questionnaire (NASS). Data was collected at baseline, one week, four weeks, eight weeks, six months and one year. The follow-up rate was reported to be 92%. No adverse of events including infection, neurologic injury or progressive herniation was reported.

After eight weeks of follow-up, the treatment group that received PRP injections, had statistically significant improvements in regards to pain, function, and overall satisfaction when compared to the control group. Functional scores remained significantly improved through 1 year of treatment. It should be noted that follow-up of the control group was only 8 weeks. No follow-up radiologic studies were conducted to determine if there were any morphologic changes.

While this study does provide data suggesting PRP as safe, efficacious option for those who suffer from low back pain due to degenerative disc disease, this was a relatively small sample size and the three questions of who is an appropriate candidate for this treatment, what PRP concentration is needed to have a therapeutic effect, and how many injections are needed, remain to be answered.

In a systematic review of dextrose prolotherapy for chronic musculoskeletal pain by Hauser et al (Clinical Med Insights Arthritis Musculoskele Disord Jul 2016), the role of prolotherapy in spinal and pelvic pain was evaluated. The authors reviewed two randomized control trials looking at the effects of dextrose prolotherapy and corticosteroid injections for low back pain. One study (Kim et al) found a greater cumulative incidence of pain reduction (greater than or equal to 50%) for those given dextrose prolotherapy. However, in the second study that focused on iliac crest pain syndrome, there was no reported differences between dextrose and triamcinolone when looking at pain (VAS) and disability scores.

In another study by Hooper et al, patients with chronic cervical, thoracic, or lumbar pain showed significant improvement in pain and disability scores with dextrose prolotherapy. Dextrose prolotherapy has also been found to be effective for coccygodynia (tailbone pain) in randomized control trials and published case series.

The systematic review concluded that there is level 1 evidence that dextrose prolotherapy results in significantly greater long-term reduction in pain than cortisone injections in patients with sacroiliac (SI) joint pain. There is level 2 evidence supporting dextrose prolotherapy for short-term pain reduction vs. cortisone injection for SI joint pain. As for chronic neck, thoracic, and low back pain, there is level 4 evidence for improvement in pain and disability with dextrose prolotherapy.

This review again demonstrates that dextrose prolotherapy is efficacious for specific musculoskeletal conditions and is a safe alternative to corticosteroids in many cases.

A recent study published in the European Journal of Orthopaedic Surgery and Traumatology (Aug 20, 2016) compared cortisone injections to Platelet Rich Plasma injections for patients with a painful partial rotator cuff tear. This was a prospective, randomized controlled study that enrolled 40 patients with a symptomatic (painful) rotator cuff tear. Patients were evaluated prior the injection and at specific time intervals (6 weeks, 3 months, and 6 months) following the injection. Standardized outcome measures including the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), the Constant-Murley Score (CMS), Simple Shoulder Test (SST) and Visual Analog Scale (VAS) were utilized.

The results of the study showed that both the cortisone injection group and PRP group both received significant clinical improvement following an injection. The PRP group had superior results that were statistically significant at 12 weeks with all outcome measures. At 6 months after the injection, there was no statistical difference between the groups.

The authors of this study concluded that subacromial PRP injection should be considered a good alternative to cortisone injections especially in light of the potential complications associated with corticosteroids.

The results of this study mirror findings from a previous investigation of 50 patients by von Wehren et al (Knee Surg Sports Trauma Arthro May 2015). The theory behind the results, relates to some evidence that the platelets may help provide revascularization to the injured rotator cuff tendon.

More evidence is needed to fully support the use of PRP for the indication of a symptomatic partial rotator cuff tear. The current evidence does suggest a viable alternative to corticosteroid injections for short term relief with a lower risk of complications.

Stem cell therapy and Platelet Rich Plasma (PRP) therapies are becoming increasingly popular for the treatment of many musculoskeletal degenerative disorders. While appearing promising as a means of decreasing pain and in some cases reversing disease, there remains many unknowns in regards to the ideal concentrations, treatment protocols, and long term effects of these treatments.

Add Alpha-2-macroglobulin to the short list of treatments that fall under the umbrella of regenerative medicine. Alpha-2-macroglobulin or A2M is a naturally occurring protein in the body that inhibits proteases (enzymes) that cause deterioration of cartilage which leads to arthritis.

Three protein classes which include cytokines, matrix metalloproteinases, and ADAMTS that have been identified as the culprits that cause the breakdown of cartilage cells leading to damage of joint surfaces. A2M has been shown to inhibit or inactivate these chemicals. Researchers have found that natural concentrations of A2M in the body may not be sufficient enough to protect the joints from the development of osteoarthritis. In response, a super concentrated form of A2M has been developed which can be injected into the joints. In fact, clinical trials of A2M (phase I/II) were approved by the FDA and began in May 2015. Data from this double blind, efficacy and safety study was recently reported and phase III trials are soon to begin.

At present, A2M is only being tested on patients with osteoarthritis of the knee. Unlike cortisone treatments, A2M does not appear to have negative side effects. Furthermore, A2M protects the joint surface and decreases inflammation.

As a new biologic treatment, targeted at treating osteoarthritis, A2M therapy has the potential to one day replace conventional treatments.

A recent study published in PLOS ONE evaluated the effectiveness of Platelet Rich Plasma (PRP) in the treatment of degenerative tendinopathies. This study by Wesner et al was a pilot study utilizing both a randomized control trial and synchronous observational cohort study. The randomized group included 9 patients with a rotator cuff tendinopathy and were assigned to either PRP or placebo. The observational cohort consisted of 178 participants with various tendinopathies. Subjects who received PRP were given an injection of 4 mL into the supraspinatus and/or infraspinatus tendons (“Rotator Cuff”). Participants in the control group received 4 mL of saline. All patients were given a standardized home based exercise program (daily) for 3 months.

Study participants were evaluated based on changes in pain scores, disability index scores, and pre/post MRI findings at 3 months and 6 months. While the sample size was small in the randomized trial (N=9), the mean improvement for pain scores in the PRP group was clinically important, but was not for the placebo group. Five out of 7 participants in the PRP group (71%) had noted improvement in MRI findings after the PRP injection.

The second part of the investigation consisted of a retrospective observational cohort study. Participants received 3 to 8 mL of PRP into the affected tendon along with a standardized home exercise program. Patients in this arm of the study were evaluated at 1, 2 and 3 months following PRP injection. Pre-injection VAS (visual analog scale) pain scores were compared to follow-up scores. Of concern with this study, 65 participants (36.5%) were excluded due to incomplete data or loss of follow-up information. Statistical significance and clinical important differences were seen between pre-injection VAS scores and follow-up.

Overall, the authors presented data was positive when considering the use of PRP for tendinopathy. However, caution must be exercised with interpreting both components of this study as the number of participants in the randomized trial (N=9) was very small and there are some major concerns for loss of study participants and varying injection protocol. Statistical testing was also limited.

A new study published in the American Journal of Sports Medicine looked at the use of Platelet Rich Plasma (PRP) injections for osteoarthritis of the knee both from a safety and efficacy standpoint.

This was a small study consisting of 30 patients who received an intra-articular PRP injection in the knee consecutively for 3 weeks. Specifically, 3 to 8 mL of PRP was injected. Patients in the control group received 3 intra-articular injections of saline. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score was used to assess outcome.

The results showed that those who received the PRP injections had a 78% improvement from baseline whereas the controls only had a 7% improvement at 12 months. WOMAC scores improved to a greater degree in the PRP group than controls starting at 2 weeks. This effect lasted throughout the duration of the study.

Overall there were no adverse events associated with the PRP injections. As this study was sanctioned by the Food and Drug Administration (FDA), the small study size was mandated to evaluate for safety. The results of this study support prior observations by Duymus et al (Knee Surgery Sports Traumatology Arthroscopy 2016) and Kavadar et al (Journal of Physical Therapy Science 2015). A recent systematic review by Meheux et al (Arthroscopy 2016) which included 6 published studies with a minimum of 6 months of follow-up also reported significant clinical efficacy for PRP injections in the treatment of knee osteoarthritis up to 12 months.

A recent case report published in the Archives of Bone and Joint Surgery has shown positive results for the use of Platelet Rich Plasma (PRP) in the treatment of a frozen shoulder. The case was a 45 year old man with adhesive capsulitis (frozen shoulder). He underwent PRP injections beginning after 7 months of symptoms. Following the first treatment, he reported a 60% improvement in pain during the day and had no pain at night. His range of motion reportedly improved significantly and a 70% improvement in function (based on the DASH – Disabilities of the Arm, Shoulder, and Hand questionnaire) was noted. The patient did receive a second PRP injection one month later.

This is the first reported use of PRP in the treatment of a frozen shoulder. A frozen shoulder or adhesive capsulitis refers to a condition in which the shoulder joint tightens up due to the capsule becoming inflamed resulting in decreased and painful range of motion.

Adhesive capsulitis usually be found in patients in the 40 to 70 year old range with a slightly higher percentage of women affected. Hormonal changes in women are believed to play a part in this.

The true underlying cause of adhesive capsulitis remains unknown. It is known that this condition can result from a traumatic event or surgery. Diabetics are five times more likely to develop this condition. This is especially true amongst insulin dependent diabetics. It is believed that the interaction of glucose molecules sticking to collagen fibers within the joint capsule may lead to or contribute to this condition.

Treatment of a frozen shoulder has traditionally focused around extended courses of physical therapy to preserve mobility of the shoulder. Anti-inflammatory medications (NSAIDs) and corticosteroids are also commonly used to reduce inflammation. Surgery is usually reserved as a last measure. A manipulation of the shoulder under anesthesia and/or a capsular release may be performed. Results have been shown to vary considerably.

Recovery is often slow, taking anywhere from a year or more.

Both prolotherapy and PRP treatments have been shown to provide positive results in the treatment of many soft tissue disorders. Several other published studies have shown the potential effectiveness of PRP in the management of rotator cuff disorders. While no solid conclusions can be drawn from this single case report, it does provide us with useful information and further investigational studies are needed to assess the efficacy of PRP in the treatment of a frozen shoulder.

In follow-up to a previous blog from October 2015 regarding prolotherapy in the treatment of rotator cuff disorders, another study was recently published showing positive results.

Lee et al (Arch Phys Med Rehab 2015) performed a retrospective case-control study evaluating prolotherapy in the treatment of rotator cuff disease. In this study, 63 patients received prolotherapy, consisting of 16.5% dextrose solution and 63 patients received conservative treatment. The outcome measures of the study included the visual analog scale (VAS), average shoulder pain score for the past week, Shoulder Pain and Disability Index Score, active range of shoulder motion, isometric shoulder strength, and medication (analgesic) use per day. At one year of follow-up, patients in the prolotherapy group received an average of 4.8 ± 1.3 injections and had significant improvements in VAS, SPADI scores, isometric strength, and active range of motion when compared with the control group.

As the authors pointed out, prolotherapy appeared to be effective in the treatment of chronic rotator cuff disease (duration of at least 3 months), however, as this study was non-randomized and retrospective in nature, the results must be interpreted with caution.

This is the second recent study to conclude that dextrose prolotherapy is efficacious in the treatment of rotator cuff disease. Bertrand et al (Arch Phys Med Rehab 2016) showed that injections of hypertonic dextrose resulted in superior long term pain improvement and patient satisfaction for those with painful rotator cuff tendinopathy. As with many prolotherapy investigations, it is often difficult to compare studies as the specific diagnosis from one study to another often differs as does the treatment protocol and outcome measures. Nonetheless, prolotherapy does appear to be beneficial for a number of musculoskeletal condition with no reported adverse events.

Platelet Rich Plasma (PRP) is the headline story of this month’s edition of The American Academy of Orthopaedic Surgeons (AAOS) publication AAOS Now. The article titled, “PRP: Does it Do Anything?” was written by senior author, Scott Duncan, M.D., MPH, MBA, who is the current chairman of the Department of Orthopaedic Surgery at Boston University Medical Center along with three orthopaedic surgical residents. As presented in the article, the optimal platelet concentration for PRP is believed to be 3 to 5 times that of whole blood. This does appear to be consistent with other published review articles. Concentrations higher than this may actually pose a detriment to healing. Previously discussed by PRPPROLOTHERAPYTAMPA and duplicated in this article, the literature continues to slowly expand with high quality investigations, but the biggest problem remains in trying to compare studies. Significant differences in PRP preparation, injection technique and treatment protocols for a specific musculoskeletal condition presents challenges when trying to assess the evidence. In some cases, published studies have had a sound methodological plan, but have had small samples sizes. PRP has been used to treat a wide array of disorders, but again we have not yet truly defined what it is clinically appropriate for.

This article by Parisien et al does discuss the use of PRP for conditions including osteoarthritis, fracture care, lumbar fusion, and ACL reconstruction. The potential benefits of PRP along with selected studies including randomized clinical trials (level I and II evidence) in some cases, were presented but the general conclusion is that limited evidence currently exists to support use for these specific conditions. It was noted that there is some benefit shown for the application of PRP into the patellar and tibial plug donor sites in ACL reconstruction. Two quoted studies were used in this assessment which have shown improved postoperative VAS scores and decreased patella tendon gap on MRI 6 months post-operatively.

In the opinion of PRPPROLOTHERAPYTAMPA, this review article published in AAOS Now does paint a realistic picture of the current state of PRP use in orthopaedics. PRP is widely used to treat a multitude of soft tissue and bony disorders and may be an effective alternative treatment but we still do not have firm evidence to support this. Standardization of PRP preparations, administration, injection protocols and outcome measures are imperative if we wish to be able to define effectiveness and eventually produce evidenced based treatment algorithms. The overall conclusions published by the authors of this paper are very similar to that of the consensus drawn from the 2011 AAOS Now PRP forum.

Several anecdotal and case reports have previously appeared in the literature regarding the intradiscal use of Platelet Rich Plasma (PRP) for low back pain.

Within the last 6 weeks, two recent studies have been published evaluating the use of Platelet-Rich Plasma in the treatment of low back. Tuakli-Wosornu YA et al (PMR 2016) looked at single injections of PRP into symptomatic degenerated lumbar discs in 47 patients. This was a prospective, blinded randomized controlled study. Data collected included pain, physical function, and patient satisfaction scores at initial visit and up to 1 year. The authors did utilize validated outcome measures. After 8 weeks of follow-up, statistically significant improvements were seen in pain scores, function scores, and patient satisfaction. No adverse events were reported. Methodologically, this was a well-planned and reported study, however, outcomes between the PRP treatment group and controls were only measured out to 8 weeks.

In another recent study by Levi D et al (Pain Med 2015), 22 patients received intradiscal PRP for chronic discogenic low back pain. This was a prospective trial evaluating a one injection protocol. Outcomes were based on Oswestry Disability Index (ODI) scores and Visual Analog Scores (VAS). Clinical success was defined if a patient achieved at least 50% improvement in both the ODI and VAS scores. After 1 month, 14% had achieved clinical success. This number grew to 47% at the 6 month mark.

Again, these results are encouraging but more well controlled trials with larger number of patients and longer follow-up periods is needed to fully evaluate the effectiveness of this treatment.

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